FDA's Pharma-First Focus Driving Medical Device Tech Away From The US

from the total-failure dept

Five years ago, we wrote about Andy Kessler's excellent book, The End of Medicine, a book I still think about frequently. Kessler's book explores why medical innovation hasn't followed the same innovation curve as every other technology space, where the technology gets better while the prices get cheaper. There are many reasons described in the book, but one key hurdle? The FDA. And it's not just the FDA's process, but the entire concept of the FDA, which is set up to approve or disapprove drugs. That's it. It's not designed to help review what will make people healthy. And for that reason, it pretty much ignores medical devices and technology. This was a big problem described in the book, and a few FDA folks in the book suggested the FDA was working on solving that issue. But it's been five years, and new reports suggest nothing much has changed.

The regulatory environment could present problems for any such device. "The Food and Drug Administration has stated that it will not certify tech that makes a diagnosis directly," said Ross Mitchell, the author of a study published last week that shows that strokes can be diagnosed with the aid of a smart-phone application with the same degree of accuracy as with a hospital computer.

Bartholomew says that because of FDA restrictions, the contest could lead to innovations that might only be used outside the United States.

Indeed, the report points to many other examples of useful new technologies showing up elsewhere, but not in the US due to the FDA. So why is the FDA so bad at actually helping people get healthy? Take a guess. It seems like regulatory capture has taken hold of the FDA in a big bad way. Just recently, we discussed how the FDA has set up a system to limit competition in the medical field to just a few giant pharma companies, and has been actively banning cheaper drug competitors, in order to help big pharma companies jack up the prices on old medicines.

While the FDA is supposed to be keeping us healthy, it looks like its general focus is on keeping the profits of a few pharma firms healthy instead.

medical innovation

Kessler's book explores why medical innovation hasn't followed the same innovation curve as every other technology space, where the technology gets better while the prices get cheaper

Sounds like a book well worth ignoring, considering that initial premise is completely wrong !.

Give some examples of what 'technolgoy' has outstriped medical innovation ?

What about "auto-industry" or 'car' technology, we are still using the internal combustion engine, still burning petrol, no REAL innovation, and no major new innovations.

Electronics ?

No again, we are still using 'transistors' with incremental advancements, no real major advancements there.

Software ?

No again, software is the WORST, it appears not to be able to keep up with hardware, (and as I said, hardware is not THAT innovative).. just incremential improvements.

Power Generation ?

NO again, we are still burning coal mostly, and "wind, solar, alternative" are not that 'innovative'.

Nuclear Power, No real advancement there either ! and we've had it for a long time.

FUSSION - We know about it, but we cannot make usable power from it, probably will not for another 40 years.

Mathematics: ?

No majory descoveries since newton's calculus, just incremental changes.

But "medicine"

You gotta be crazy to think that the curve of innovation in medical science has not far outpaced MOST if not ALL other technologies. It is way above the 'curve'.

The biological sciences is "WHERE IT IS ALL HAPPENING" these days, and NOT technology, and NOT software/hardware which is really a very stagnent technology.

We've discovered DNA, we've sequenced it for many species including human, we've discovered vast amounts of new compounds and methods for doing amazing biological things, we've been able to take DNA and BUILD LIVING THINGS !!

We've developed amazing technologies for medicine and techniques for diagnosis and treatment, surgical techniques are advancing at an increadable rate.

One day you may get very sick, and then you will quickly find out that being able to copy for free music does not matter anymore, or the FDA or anyone else.

But you will most certainly be VERY happy when the Doctor say to you. "It's ok, now that you have come to me, YOU WILL NO LONGER DIE, as I know just the technology that will save you."

or if you ever wonder just how lucky you are that you have two arms and legs and all your fingers because your mother did not take Thalidomide to relax when she was pregnent with you !!

Thank you FDA nice catch, if you ever want to know why FDA approval is so high just think one word....

Thalidomide

may be we should just forget the FDA and let anyone produce anything and call it Medicine, and just hope for the best..

Also, bureaucrats' incentives are rarely aligned with the our incentives (whether we are producers or consumers). The biggest motivator for a bureaucrat is CYA: They will always err more on the side of failing to approve a drug/treatment/device that is safe and effective rather than approving a drug/treatment/device that may turn out not to be safe or effective. Who can forget AIDS patients being denied experimental drugs in the 80s? --apparently, many.

Both of these types of errors will happen when decisions are made in the face of uncertainty. There is a trade off between the two types of errors. You cannot have a process designed and run by people whose sole motivation is to avoid trouble that is not biased heavily towards shooting down promising, unconventional approaches while overreacting to every risk. Has anyone asked how many chickens were burned alive during the height of the bird flu craziness? How about the economic loss from swine flu?

CYA is the bureaucrat modus operandi. It leads to the current state of the TSA. It leads to all sorts of consumer protection agencies actually decreasing consumer welfare by limiting choice. Shareholders of drug companies do not want their customers to die and shareholders of airlines do not want their planes to be taken over by terrorists. Until we understand that, there cannot be sane regulation.

By the way, regulatory capture by producers is a fairly week explanation of why economic regulation exists mostly outside of the areas where economic reasoning might indicate that it might actually increase social welfare. I would recommend another Peltzman classic, Toward a More General Theory of Regulation to understand better how regulators and politicians behave.

Re: medical innovation

Yes, and most of those seminal developments have come out in the field.

What's being argues here isn't that pharma companies are not necessary, but that the focus solely on pharma is not the best way to go. For example, a considerable percentage of medical innovations are occuring in the EU, such as the retinal laser attachment surgery, which is being perfected at the University of Manchester, in collaboration with other universites and specialists.

And a large part of the reason for little innovation in the petrochemical fields is because they were partially suppressed by oil companies. Innovation in this area is still ongoing.

Re: medical innovation

You do realize that using your curve for mathematics as a base line, medicine is woefully behind. Though, you probably wouldn't since you probably don't pay attention to people like Stephen Hawking. And since you don't know that resisters and transistors are those in name alone (nothing like their originals), then I can see why you don't understand just how far behind the curve medical technology and medicine truly are.

And being so completely out of the loop would also explain why you think anyone is calling for the dismantling of the FDA.

Ah, so this is why in over 20 years nobody's developed a way to get fluids into or out of the body aside from a needle. If a Star Trek-type hypospray were developed and put into use, it's likely more people would get vaccinated and more would give blood, since there would be no needle to be anxious about. Not to mention that numbing people up for things like dental procedures would be much smoother as well.

And being so completely out of the loop would also explain why you think anyone is calling for the dismantling of the FDA.

I wouldn't say a total dismantling would be good. We need an agency that protects the people from bad pharma.

But as it stands - we have no agency that does that now. Only one who takes lots of kickbacks from pharma - at least, that's the way it seems. It's amazing some of this garbage gets approved, but I guess it keeps trial lawyers busy.

Re:

Think about it. If you have a dishwasher that doesn't clean your dishes, what do you do? You replace it or stop using it.

If you have a car that barely runs and you're lucky if it gets you where you are going, what do you do? You replace it.

Same for just about anything in your life. If it does not provide the good or service you expect, you replace it.

Sure you could probably repair those things but often the same issues or new issues come up. This was the reason I bought a new care rather than try to maintain my old one. I got tired of repairing new problems every 3 months.

So it should go without saying that if the FDA is not protecting us from bad medicine and food and is actually increasing the cost of medical care in the US, we should replace it or just get rid of it entirely.

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Actually the military uses a similar technology. I believe they are call Jet Guns. A friend was talking about them when he was shipped off to Vietnam a while back. It was how the military immunized the soldiers before putting them on the planes.

Re: medical innovation

Darryl, if you'd bother clicking any of the provided links in the article....

Give some examples of what 'technolgoy' has outstriped medical innovation ?

Citron cites several cases in which European patients benefited from early access to new medical devices: Deep brain stimulation to treat Parkinson's disease by 44 months; a ventricular support device to improve circulation by 29 months; a pacemaker device to manage irregular contractions in failing hearts by 30 months. Why is this happening? Citron maintains:

What's behind this erosion of leadership and late access to innovations? Simply stated, an overreaching, overly burdensome, and sometimes irrelevant Food and Drug Administration regulatory process for the most sophisticated new medical devices.

Electronics ?

Really, no advancements in electronics? Have you even left your house recently? Are you still using a PC from 1990 with CRT monitor attached to the keyboard, and a 300 baud modem? Probably not. Walk into a Best Buy, Conn's, or even Wal-Mart, Sams, Costco, Target or any other store with an electronics department. What you won't see is the crap you have in your house like 27" console TV's that weigh 400 pounds, 8 track tapes, or even cassette tapes.

Take a look around at all the smart phones, flat panel tv's of all sizes (hey, one person can carry two 27" tv's now!), surround sound to go with those tv's, internet speeds much greater than your 300 baud modem is getting.

I could sit here and rip apart your claims in the other areas, too. I just don't have time. Some of us work, you know. So please, Darryl, put on your sunglasses, some SPF 100, and emerge from your cocoon and join us in the real world. I know it may be scary for you, but you can do it.

My father is a diabetic, he requires shots 3x / day at different amounts based on his current blood sugar levels. He asked me (a programmer) what it would take to build a device that could automate this task.

My short response was, "it can be done but it would cost to much to approve".

Based on the following:
Insulin pumps already exist, However they can only pump a set amount.

Devices that sample blood exist, However they are not designed to talk to insulin pumps.

To put both devices together (say with an Iphone as a manager) would never get approval, there are crazy requirements at the FDA that a device not be a general computing device, as well as insane health and safety requirements.

In addition Medicare will not approve any device that uses consumer electronics as its delivery method. There is some fear built into the system for wasting money on Iphones and instead require purpose built medical devices.

Medical devices also have some fairly insane requirements for use. Every device needs to have its history tracked. If one brakes and causes someone to die the maker can be held liable. Its ugly.

I think that while there are some good points being made here, we should be a bit more careful about claims such as comparing the rate of innovation in different sectors. Both the delimitations of sectors and the measurement of rates of innovation is very arbitrary. For instance: An on-board computer that catches you falling asleep in your car. Is that car industry, computer industry, transportation industry, safety industry, consumer cars industry? How many "innovation points" is it worth? Just play with the parameters enough and without leaving the realm of honest answers, you can provide evidence for anything you want.

However, it is most definitely true that the FDA is limiting the speed and quality of innovation in the medical industry. I think overall, this is a problem that partisans of regulation often forget: Innovation comes faster than you think and mostly in ways you cannot even imagine. Your regulatory entity will inevitably be unprepared for those innovations and make a mess of things either by being completely bypassed or by getting in the way.

Re: Re: medical innovation

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That's heartbreaking. My dad is an insulin-dependent diabetic and I grew up with several friends with juvenile diabetes.

It seems like a no-brainer to modify an implanted morphine pump that had an additional sensor to measure blood glucose and dispense it at a moderate rate. Think of all the money and pain it would save since patients would suffer fewer effects of swinging blood sugar levels!

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General computing devices most certainly should be banned in medical devices that directly interact with patients. Those things are not designed for absolute reliability in mind, even though they are becoming very, very reliable. But the failure mode of general computing devices are just too unpredictable to be safely used in devices affecting life and death.

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Well, they surely will never be designed with medical uses in mind if we ban their use in medical uses.

A lot of smart scientists, doctors, engineers and politicians forget about what econ students learn in econ 101 (it usually doesn't stick until econ 400 to be fair): Incentives matter. This leads to many results which feel counter-intuitive to many people because it is so different from their everyday life. In your every day life, if a leg of a table is too short, you put something underneath it and your problem is solved. On the other hand, if you left the table alone, the leg would keep being shorter. In the economy, if a product is not ready for medical use and you wait, people will want to make money by making the device more reliable and eventually it will be ready for medical use. However, if you ban its use, well, nobody will want to improve on it. These feedback mechanisms which are second nature to economists often escape otherwise brilliant people just because they are not used to such systems. The result is bans on all "general computing devices" in medical systems resulting in cost increases and forgone innovations.

Re: Re: medical innovation

Take a look around at all the smart phones, flat panel tv's of all sizes (hey, one person can carry two 27" tv's now!), surround sound to go with those tv's, internet speeds much greater than your 300 baud modem is getting.

Unfortunately, there's also a body that regulates (indirectly) the electronics field. It's called the Entertainment industry. If they don't like your new invention, expect to be sued into oblivion.

Re: Re:

Wrong problem?

Unless I am woefully misinformed, I'm not sure why FDA not controling the medical devices would be a problem? Since the devices themselves aren't for curing any illnesses, then the FDA can be completely bypassed. Do the folks at FDA have to approve the heart-rate monitors? The MRI machines? I know NASA physicians have been exploring and testing biofeedback devices in their regimens and training. So why would the "tricorder" even have to be approved by the FDA? As long as the FCC signs off on the device as not producing harmful emissions, they should be good to go.

Re: Wrong problem?

It's not so much that the FDA has to approve medical devices -- they have to approve as to how they're *used*.

I have a spinal cord stimulator. It's approved by the FDA for use in certain chronic pain applications. The makers of the devices, companies like Medtronic and ANS, have found they can use to help chronic migraine patients on an experimental basis...at least that was the case last time I got a status update. Experimental procedures or uses are not covered by health insurance, which automatically makes them out of the question for most patients.

In another case of FDA approval, I cannot have an MRI because of the implant. Other countries don't have a problem with it at all, but it takes a miracle (not to mention a lot of time and red tape) to get the FDA to agree to it.

This is slightly off-topic, but the health care industry is subject to the Certificate of Need law. It creates artificial scarcity. Here in Michigan, it's gone so far as to require an OB/GYN to do a certain amount of business before he/she can have an in-office ultrasound machine. I don't know if that includes the small hand-held units, but it wouldn't surprise me if it were the case.

Re: Re: Wrong problem?

Interesting... But my post was more on the use of devices not directly involved in treatments. I know that arterial stents, pacemakers, as well as surgical procedures need approval. But do the completely external devices have to be approved as well?

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Diabetes treatment is a very good example of what's wrong. There's no money in actually curing it. On the other hand, there's a great deal of money in controlling it with drugs you have to take for the rest of your life. These are expensive because the FDA doesn't allow a free market. To add insult to injury, in order to purchase these expensive drugs, the FDA insists you first of all have to purchase permission. Most people cover that by purchasing insurance, and the insurance companies keep you coming back by making you re-purchase permission to continue living every few months. It's just one big profitable tsunami of gravy that depends on the FDA for its existence.

You know restricting competition is the direction they want to take I vehemently disagree but if they do go that route there should be some serious salary caps put in place. The system should force money into research and development in such a way that if big pharm wants to operate this way it will be done in a way that maximizes money going towards innovation and limits salaries and bonuses to CEO's, presidents, COO's, CFO's, department leads etc. Expand the research department significantly with all that extra money. Now I am not saying we should pay the researchers minimum wage, they spent a lot of time and money to get where they are and we can afford to reward that effort but lets reward the people doing the work rather than the ones signing off on it.